martes, 5 de mayo de 2020

World to Gilead: Don't mess this up. Plus: Insider sales of a hyped-up stock & how to run a trial in a pandemic

The Readout
Damian Garde & Meghana Keshavan

As Gilead picks a price for remdesivir, the rep of an industry hangs in the balance

The novel coronavirus pandemic has brought an opportunity for the pharmaceutical industry, long castigated as greedy and predacious, to demonstrate its worth to the world. But whether that chance is seized or squandered rest, for now, on Gilead Sciences and its much-discussed treatment for Covid-19.

In interviews with STAT, analysts, drug pricing experts, activists, and lobbyists — including those who work with Gilead — underscored the monumental challenge facing the company as it prepares to set a price for remdesivir, the intravenous medicine slated to win approvals around the world.

Charge too much and Gilead will invite the scorn of the world, likely reigniting the bipartisan push in Washington for sweeping reforms to America’s drug pricing system. But if Gilead bends to activists and charges very little, the company is unlikely to recoup the roughly $1 billion it expects to spend developing the drug, disappointing investors and tanking the stock price. Sitting on the fence could leave both sides unsatisfied.

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This CEO touted a Covid-19 treatment while selling his stock

In a series of press releases and video chats, the CEO of a microcap biotech has claimed his company’s drug had “saved” the lives of patients with Covid-19, gassing the stock price. All the while, he was angling to sell more than half of his stake in the company at its inflated valuation.

As STAT’s Adam Feuerstein reports, CytoDyn CEO Nader Pourhassan has spent weeks hyping leronlimab, a virus-blocking treatment, as a potential treatment for Covid-19 despite no supporting data. CytoDyn, previously a penny stock, rose more than three-fold since March.

What Pourhassan didn’t mention in any of those exuberant YouTube appearances was that he had filed with the SEC a plan to sell 4.8 million shares of the company. And he filed it without also posting to the agency’s searchable database, which isn’t illegal but which makes it difficult for the public to discover.

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How do you run a trial when patients keep disappearing?

China’s declining number of novel coronavirus cases proves that good news for humanity can spell a setback for drug development.

As STAT’s Andrew Joseph reports, the public health successes that have driven down rates of Covid-19 also mean it’s harder to find patients for clinical trials of new treatments and vaccines. Over the past two months alone, Chinese studies of remdesivir and hydroxychloroquine were hampered by a lack of available subjects.

The long-term problem, researchers say, is that studies end up moving forward with too few participants, no control group, or incomplete data. That makes it difficult to discern whether a given medicine was actually effective, which could prove perilous if the coronavirus turns out to be a cyclical problem for the globe.

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Lockdown or no, biotech remains expensive

The coronavirus outbreak has forced biotech companies to shut down offices, downscale labs, and delay clinical trials. But discovering medicines is still a cash-intensive business, and disruptions the size of a pandemic can threaten to put startups out of business.

Gregg Beloff, managing director of Danforth Advisors, makes his living advising biopharma companies on how not to go bankrupt. Writing in STAT, Beloff’s advice is to stay calm and focus on what you can control.

All contracts — whether with vendors, landlords, or outsourcers — can be renegotiated. Virtually all companies also have unnecessary spending that can be paused in a crisis. And when the money runs low, there are still opportunities to raise capital, provided you know exactly what you need to get through it.

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More reads

  • Orphan drugs improve health — but aren’t priced cost-effectively, study finds. (STAT Plus)
  • With coronavirus pandemic, venture capitalists are taking extra precautions. (Boston Globe)
  • Watch: How does Gilead’s experimental drug remdesivir work against the coronavirus? (STAT)

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